Coaxial Drainage Versus Standard Chest Tube After Pulmonary Lobectomy

Lung Cancer Clinical Trial

Official title:

Coaxial Drainage Versus Standard Chest Tube After Pulmonary Lobectomy: a Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04877925
• Other study ID #: COAXIAL
• Status: Completed
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: November 30, 2020

Study information

• Verified date: May 2021
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Objectives: Chest tubes are routinely inserted after thoracic surgery procedures in different size and numbers. The aim of this study is to assess the efficacy of Smart Drain Coaxial drainage compared with two standard chest tubes in patients undergoing thoracotomy for pulmonary lobectomy. 98 patients (57 males and 41 females, mean age 68.3±7.4 years) with lung cancer undergoing open pulmonary lobectomy were randomized in two groups: 50 received one upper 28-Fr and one lower 32-Fr standard chest tube (ST group) and 48 received one 28-Fr Smart Drain Coaxial tube (CT group). Hospitalization data, quantity of fluid output, air leaks, radiograph findings, pain control and costs were assessed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: November 30, 2020
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age more than 18 years

• patients scheduled for pulmonary lobectomy

Exclusion Criteria:

• middle lobectomy,

• extended resections, minimally invasive lobectomies,

• previous ipsilateral thoracic surgery,

• induction chemo and/or radiotherapy

• patients who did not give consent to participate.

Related Conditions & MeSH terms

• Lung Cancer

Intervention

Device:
• standard chest tubes
2 standard postoperative chest tube used
• coaxial chest tube
1 postoperative smart drain coaxial tube

Locations

Country	Name	City	State
Italy	Sapienza University of Rome	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Marco Anile

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Guerrera F, Filosso PL, Pompili C, Olivetti S, Roffinella M, Imperatori A, Brunelli A. Application of the coaxial smart drain in patients with a large air leak following anatomic lung resection: a prospective multicenter phase II analysis of efficacy and — View Citation

Rena O, Parini S, Papalia E, Massera F, Turello D, Baietto G, Casadio C. The Redax(®) Coaxial Drain in pulmonary lobectomy: a study of efficacy. J Thorac Dis. 2017 Sep;9(9):3215-3221. doi: 10.21037/jtd.2017.08.110. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daily fluid drainage (mL)	Quality of fluid drainage evaluated in mL and by means of a chest X rays	1 postoperative day
Primary	Presence of postoperative pneumothorax	Quality of air drainage evaluated by chest X rays	1 postoperative day
Secondary	presence of pneumothorax after tubes removal	Pneumothorax evaluated by chest x rays	within 24 hours after tubes removal
Secondary	evaluation of pain measured by Visual Analogue Scale	evaluation of patient's pain with a 1 - 10 scale ( 0 no pain - 10 maximum pain)	1 postoperative day
Secondary	Analysis of costs (in euros)	Evaluation of hospital costs in euros during the hospitalization	until discharge, an average of 6 days
Secondary	Postoperative hospitalization (in days)	Duration of hospitalization in days after the operation	until discharge, an average of 6 days